Carbetocin is an investigational drug that was created to have effects in the body like oxytocin. Carbetocin is not approved in the United States, but is approved in some other countries for treatment of women with excessive bleeding after giving birth via caesarean section.
Carbetocin has been studied by Ferring Pharmascience Center for the treatment of PWS in a Phase 2 study at Vanderbilt University, University of Florida and Winthrop University. Further development, including the Phase 3 study, will be pursued by Levo Therapeutics. The Phase 3 study is expected to enroll individuals with PWS, age 7-18 years old, who will receive carbetocin or placebo by intranasal spray. Effects on hyperphagia (excessive appetite), will be measured. An ‘open label’ period, where all participants can receive carbetocin for at least a year, is planned. Plans for the Phase 3 study are subject to change. https://www.levotx.com